Before hiring any individual or onboarding a new vendor, healthcare organizations that participate in federal healthcare programs such as Medicare or Medicaid must complete due diligence and check to ensure that the individual or entity is not excluded from participating in federally funded healthcare programs.

The Department of Health and Human Services Office of Inspector General (HHS-OIG) maintains an exclusions list consisting of individuals and entities that have been prohibited from participating in federal healthcare programs. Individuals and entities are added to the List of Excluded Individuals and Entities (LEIE) after being found guilty of fraud, abuse, or neglect, although they may be added to the list for other reasons at the discretion of HHS-OIG.

Failure to check the LEIE and subsequently billing federal healthcare programs for products or services provided by an excluded individual or entity can result in a significant fine. In addition to pre-engagement checks of the database, healthcare organizations must conduct regular checks of the LEIE for existing employees, contractors, and vendors. All checks must be documented to maintain an audit trail.

Free Webinar on Sanctions and Exclusions Compliance

Readers of the HIPAA Journal are invited to attend a free webinar, where they will be able to hear from leading compliance experts who will give their expert advice about implementing and maintaining an effective screening program that goes beyond the basic requirements to include establishing and managing conflict of interest programs.

The webinar – The Complete Exclusion Screening Playbook: From Sanctions to Conflicts of Interest – will take place on Tuesday, September 9, 2025. You can find out more and register for the event here.

Recent LEIE additions and Financial Penalties

HHS-OIG has recently announced four new additions to the LEIE, and one financial penalty for a healthcare provider for employing an excluded individual and billing federal healthcare programs for products or services provided by that individual.

• Kidspeace National Centers of New England, Inc., in Ellsworth, Maine, was discovered to have employed an excluded speech pathologist. In this case, the individual was not employed directly, but through a contractor. The alleged violation was settled with HHS-OIG on July 31, 2025, with a $44,736.78 financial penalty.
• Brant Jolly, of Fayetteville, Arkansas, has been excluded from participating in federally funded healthcare programs for 10 years for violating the False Claims Act by causing the submission of false claims to Medicare for lab tests that were either never ordered, never rendered, or involved deceased beneficiaries.
• Nirmal Mulye, PhD, based in Miami, Florida, was added to the LEIE by HHS-OIG for defaulting on payment obligations. Dr. Mulye had previously founded a company that was determined to have underpaid Medicaid rebates, then defaulted on his payment obligations under an active settlement agreement. Dr. Mulye will remain on the LEIE until reinstated by HHS-OIG after curing the default.
• Andres Gomes, MD, of Puerto Rico, defaulted on his payments under a False Claims Act settlement agreement with the Department of Justice and HHS-OIG. The settlement agreement resolved allegations that Dr. Gomes did not pay proper remuneration to physicians for patient referrals to clinics for the surgical treatment of peripheral arterial disease. Dr. Gomes will remain on the LEIE until he cures the default.

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